Method and system of monitoring a patient

ABSTRACT

A patient monitor system implemented by a service provider for users via recording a patients analytes measurements by an attenuated total reflection (ATR) infrared total spectroscopy method. The system comprises an input module that provides a non-invasive method in measuring analytes in a patient, such as a measurement of the glucose level and other blood analytes. The measurement is shared among a plurality of output devices such as computers, personal digital assistants (PDAs), cellular phones, and pagers that are stationed or held by various users such as doctors, patients, researchers, pharmacies, labs, and health insurers. In addition behavioral attributes are recorded and correlated with the analytes measurements to generate a profile. The profile is selectively sent to output devices based on the user profile corresponding to the output device. Also, access to the profile is monitored by a security module that encrypts the profile to prevent access by un-authorized users.

BACKGROUND INFORMATION

[0001] 1. Field of the Invention

[0002] The invention relates in general to devices and methods forimproving the delivery of patient information and care to patients,particularly to transactions involved in utilizing a non-invasivemonitoring system to deliver physiological information to patients andpatients' service providers.

[0003] 2. Description of Related Art

[0004] Numerous diseases require the monitoring of various physiologicalattributes of a patient. These attributes such as blood glucose leveland other blood analytes' level are invaluable to patients and healthservice providers such as doctors, medical professions, pharmacies,researchers insurance companies, and government agencies.

[0005] Particularly in patients with diabetes, monitoring the level ofblood glucose is extremely important in controlling the patient'shealth, and decreasing or delaying the damaging effects of uncontrolledblood glucose. Diabetes is a disease in which the body does not produceor properly use insulin, which results in the increase uptake of glucosefrom the blood across cell membranes. About sixteen million people inthe United States are diabetics. The American Diabetes Associationreports that diabetes is the seventh leading cause of death in theUnited States. The complications of the disease include blindness,kidney disease, nerve disease, heart disease, and death.

[0006] Specifically, for diabetes, monitoring various physiologicalattributes is essential for diabetic patients. For example, it isessential that patients practice frequent self-monitoring of bloodglucose (SMBG). Based upon the level of glucose in the blood,individuals may make insulin dosage decisions before injection.Monitoring the trends in blood glucose over time provides health careproviders with invaluable information on the adequacy of therapy, thecompliance of the patient and the progression of the disease. However,the prior systems of glucose monitoring usually requires obtaining bloodfrom a finger stick (invasive method) or obtaining body fluids (otherthan blood) and subcutaneous tissue (also an invasive method). Now, anoptical non-invasive glucose monitoring system, as illustrated in arelated co-pending U.S. patent application entitled Infrared ATR,Glucose Measurement System (11), U.S. application Ser. No. 09/547,433,by Herbert L. Berman and Jeffrey N. Roe, owned by the assignee of thisapplication and incorporated herein by reference, provides a solutionfor non-invasively gathering of blood glucose information for diabeticpatients. Use of a non-invasive technology rather than an invasivetechnology permits a significantly better approximation to continuousmonitoring, which in turn may contribute significantly to improvedhealth care for diabetic patients.

[0007] Therefore, it is advantageous to have a monitoring system thatleverages on the non-invasive glucose-measuring device to provide amedium for sharing of the monitored information.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]FIG. 1 is a block diagram of a monitor system according to thepresent invention.

[0009]FIG. 2 illustrates a more detail illustration of the internalarchitecture of a non-invasive monitor device 210 a processing unit andstorage system 510, and information recipients 600.

[0010]FIG. 3 illustrates a flow chart of registering information intothe monitor device.

[0011]FIG. 4 illustrates the step-by-step information flow from themonitor device to a data processing and storage system.

[0012]FIG. 5 is a flow chart of the information processing in a dataprocessing unit.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

[0013] Reference is made in detail to embodiments of the invention.While the invention is described in conjunction with the embodiments,the invention is not intended to be limited by these embodiments. On thecontrary, the invention is intended to cover alternatives, modificationsand equivalents, which may be included within the spirit and scope ofthe invention as defined by the appended claims. Furthermore, in thefollowing detailed description of the invention, numerous specificdetails are set forth in order to provide a thorough understanding ofthe invention. However as is obvious to one ordinarily skilled in theart, the invention may be practiced without these specific details. Inother instances well-known methods, procedures, and components have notbeen described in detail so that aspects of the invention will not beobscured.

[0014] Referring to FIG. 1, the elements of the patient monitoringsystem in accordance with one embodiment of the invention consist one ormore non-invasive analyte monitor devices (110 210 310 410), a dataprocessing and storage unit 510, and one or more information recipients600, such as doctor office 610 researcher 620, pharmacy 630,hospital/labs 640, insurance provider 650, government agency 660,patient 670, family member 680, and health maintenance organization 690.All elements of the system can communicate with each other via a networkor wireless protocol 50.

[0015] As illustrated in more detail in FIG. 2, the data processing andstorage unit 510 implements for a user a monitoring system thatorganizes and processes physiological and behavior attributes of theuser to enable transmission of these attributes to informationrecipients 600. The term “information recipients”as defined herein areperson, organization, and corporation that are interested in theattributes gathered by the non-invasive analyte monitor device such asdoctor office 610, researcher 620, pharmacy 630, hospital/labs 640,insurance provider 650, government agency 660, patient 670, familymember 680, and health maintenance organization 690. Optionally, thedata processing and storage unit can be programmed to send automatedwarnings such as by email, phone, or fax to a patient or informationrecipients if the patient's condition falls outside an acceptable limitthat can be prescribed by the patient's caregiver or physician.

[0016] In one embodiment of the system where the user is a diabeticpatient, the user utilizes the non-invasive analyte monitor device 210based on attenuated total reflection (ATR) technology to measure bloodglucose level. The analyte monitor device comprises an ATR plate 212coupled to an analyte measurement generator 213 which calculates theblood glucose level on user's skin that is placed on the ATR plate 212for measurement. The measurement is then stored in a storage module 214,which also can store other user information. The analyte device 210requires calibration, which is accomplished by a calibrator module 215that correlates the measurements generated from the analyte measurementgenerator 213 to measurements taken from standard invasive proceduressuch as a finger stick. After calibration, the analyte device 210 can beused to obtain accurate glucose level measurements without any otherinvasive procedures. The input/output module 216 allows the user toinput information and also receive the analyte measurements from themeasurement generator 213 or the storage module 214.

[0017] In an alternative embodiment, the user, via the input/outputmodule 216, may also input behavior attributes such as time durationbetween analyte measurement and last meal, time duration between analytemeasurement and last exercise session, time duration between analytemeasurement and last resting session or time and dosage of medicationtaken. These behavior attributes affect the interpretation of the bloodglucose measurement. For example, blood glucose level tends to be higherfor users that have just eaten a meal. Thus, by adding behaviorattributes, the monitor, system can provide a better profile of theuser's health to information recipients 600 such as the user's doctor610. Also, the user utilizes the input/output module 216 to includeother physiological attributes such as heart rate or blood pressure.Optionally the input/output module 216 can comprise an activity sensorthat determines energy use and/or a metabolic activity sensor thatmeasures metabolic rates such as oxygen consumption.

[0018] Additionally, the output module 216 of the analyte device 210serves as a messaging terminal for the patient. These messages can beautomatic alarms that alert the patient when the analyte measurements,behavior attributes and physiological attributes are out of a normalrange prescribed by the patient, the patient's caregiver, and/or thepatient's physician. These messages can be generated by the analytedevice itself or from any one of the information recipients. Forexample, if the patient's physician determines that the patient is notresponding to a prescribed medicine dosage, the physician can send amessage to the output module 216 to request the patient to change hisdosage or to request a visit to the physician's office for consultation.

[0019] All the analyte measurements, behavior attributes, andphysiological attributes are communicated to the data processing andstorage unit 510 for processing and storage, which will be furthereddescribed in detail in FIG. 5. These attributes are sent to the dataprocessing and storage unit 510 via a network such as the Internet,local area network (LEN) and/or Slide area network (WAN), wirelessand/or wired or other network infrastructure 50. In one embodiment orthe invention, the monitor device 210 has its own wireless transmissionmodule. In an alternative embodiment of the wireless transmission, themonitor device 210 is coupled to a wireless device such as a cellularphone, a pager or a wireless modem to enable transmission. Optionally,due to the large amount of data being collected, the monitor device 210may send all information to a local terminal and storage located withina patient's home, a physician's office, or a hospital. The informationto the local terminal can be transmitted over a short-range radiofrequency (RF) link (e.g. Blue tooth). Subsequently, the informationstored at the local terminal will be communicated to the processing unit510.

[0020] After communication is established between the monitor device 210and the processing unit 510, an account manager 512 in the processingunit 510 accesses the user's account and the security module 511verifies the user's identity via a password or any other security means.After verification, the attributes are transmitted and organized into aphysiological database 513, which stores the user's analyte measurementsand other physiological attributes, and a behavioral database, whichstores the user's behavioral attributes. The account manager 512 alsocommunicates with an information recipient database 515 that includesthe user's selected information recipients 600 and recipient parametersassociated with each specific information recipient. These recipientparameters as described herein are requirements that direct thetransmission of the user attributes, which may include type ofinformation such as report of blood glucose level, all email to alert ifblood glucose level reaches a certain maximum or minimum, a report ofbehavioral and blood glucose correlation, “time of information” such asweekly, monthly, or quarterly, “format type” such as a graphicalrepresentation or text, and “information recipient” such as sending theinformation to doctor and patient personal computer, or sending tofamily members in case of emergency.

[0021] The processes of gathering the user's attributes, processing theattributes, and transmitting the attributes to corresponding informationrecipients are furthered described in detail in FIG. 3, whichillustrates the registration of the user, in FIG. 4, which illustratesthe gathering of the user's attributes, and in FIG. 5, which illustratesthe data processing and transmission of the attributes.

[0022]FIG. 3 illustrates the events that take place in userregistration. The user can register via the monitor device 210 or anycomputing machine that enables communication to the processing unit 510.The user logs-in and account registration is initiated 3000 if user hasnot registered. The user provides account information (e.g. name,address, date of birth, prior medical history, or monitor device serialnumber). The user then creates 3100 a profile, which is a set of datarelating to a specific service (e.g. monitoring the blood glucose levelor monitoring alcohol level) by selecting 3200 the type of serviceneeded such as analyte measurement reading, analysis and tracking ofphysiological and behavioral attributes, transmitting information amonginformation recipients, or any combination of the above mentionedservices. After service is selected 3200, the user selects one or morephysiological attributes to track 3300, one or more analytes to bemeasured 3400 and one or more behavioral attributes to track 3500. Ifinformation transmission among recipients is selected in step 3200, theuser needs to input all recipients' information and recipient parameters3600. The profile is stored in the storage module 214 of the monitordevice 210 and in a profile database 516 in the account manger 512 ofthe processing unit 510. Alternatively the profile can be stored oneither the storage module 214 or the account manger 512. Profile iscompleted 3700 and the data processing unit sends a confirmation withpassword to the user and his list of recipients. Alternatively, the usercan create numerous profiles within the same account.

[0023] After user registration, the user can utilize his device togather physiological and behavioral attributes, which is illustrated inFIG. 4. The user logs-in 4000 to the device 210 with password from theregistration and user account is presented by the input module 4100.Alternatively, user log-in can be accomplished by voice recognition orby a fingerprint. The user selects the desired profile 4200. If behaviorinputs are required, the user inputs 4300 the behavior attributes suchas time duration between analyte measurement and last meal, timeduration between analyte measurement and last exercise session, timeduration between analyte measurement and last resting session, orwhether other drugs or alcohol was taken prior to measurement. If nobehavioral attributes are required, the user is presented withopportunity to select analyte measurement. If selected, the user selectsthe desired analyte to be measured 4400 and if calibration is needed,the calibrator module is initiated to calibrate 4500 the analytemeasurement generator 213. If calibration is complete the user can placehis finger 4600 on the ATR plate and the analyte measurement generatorrecords 4700 and calculates the analyte level. If only the analytemeasurement is selected and no processing is needed, the output module216 of the monitor device 210 will display the measurement. If furtherprocessing is required, the data is sent 4800 to the processing unit andthe data is processed, as illustrated in more detail in FIG. 5.

[0024] In FIG. 5, the data processing unit 510 receives transmissionfrom the monitor device 5100. The user is verified 5200 via the securitymodule and user account is accessed 5300 by the account manager. If thetransmission pertains to an existing profile, the data is transferredand the profile database in the account manager is updated 5700. If thetransmission consists of data pertaining to a new profile, a new profileis created by the processing unit 5400 and data is transferred 5500. Theprocessing unit then organizes and correlates the data according to thebehavioral and physiological relationships and recipient parameters 5600and updates the profile database in the account manager 5700. Afterupdating the profile database 5700, the account manager is responsiblefor sending out the corresponding reports and profiles at thecorresponding time to each recipient based on the recipient parameters5800. Alternatively, the reports and profiles are encrypted and accessis only granted to recipients with valid passwords to preventunauthorized use.

[0025] Foregoing described embodiments of the invention are provided asillustrations and descriptions. They are not intended to limit theinvention to precise form described. In particular, it is contemplatedthat functional implementation of invention described herein may beimplemented equivalently in hardware, software, firmware, and/or otheravailable functional components or building blocks. Other variations andembodiments are possible in light of above teachings, and it is thusintended that the scope of invention not be limited by this DetailedDescription but rather by claims following.

We claim:
 1. A method for implementing a patient monitor program for auser by a service provider, the method comprising the steps of:recording a physiological attribute of a patient on a device, whereinthe device utilizes attenuated total reflection (ATP) infraredspectroscopy to record the attribute; and sending the attribute to oneor more users via at network.
 2. The method of claim 1, wherein theattribute is blood glucose level.
 3. The method of claim 1, wherein theattribute is a blood analyte level.
 4. The method of claim 1, furthercomprising the step of processing one or more attribute to generate aprofile of the patient.
 5. The method of claim 1, further comprising thestep of recording one or more behavioral attributes of the patient. 6.The method of claim 5, further comprising the step of correlating thephysiological attributes with the behavioral attributes in generatingthe profile of the patient.
 7. The method of claim 6, further comprisingthe step of encrypting the profile to protect unauthorized access. 8.The method of claim 1, further comprising the step of transmitting theattribute wirelessly.
 9. The method of claim 8, wherein the wirelesstransmission is performed via coupling the device to a cellular phone.10. The method of claim 8, wherein the wireless transmission isperformed via coupling the device to a wireless transmitting device. 11.The method of claim 1, wherein the attribute is transmitted to a localprocessing unit over a short range radio frequency (RF) link.
 12. Themethod of claim 11, wherein Blue tooth protocol is utilized in thetransmission.
 13. A patient monitor system to enable sharing ofinformation among information recipients comprising: an input device torecord an attribute of an patient, wherein the device utilizesattenuated total reflection (ATR) infrared spectroscopy to record theattribute; a data processing unit to process the attributes to generateand transmit a profile of the patient to a recipient.
 14. The system ofclaim 13, wherein the profile is transmitted via a network.
 15. Thesystem of claim 13, wherein the profile is transmitted wirelessly. 16.The system of claim 13, wherein the profile is transmitted based onrecipient parameters.
 17. The system of claim 13, further comprises asecurity module to verify recipient access to profiles.
 18. A method oftransmitting an analyte measurement from an input device to a useroutput device comprising the steps of: contacting a skill surface of apatient to an ATR plate in said input device; no recording an analytelevel measurement in the skin via ATR infrared spectroscopy; andtransmitting said analyte level measurement to one or more user.
 19. Themethod of claim 18, wherein said measurement is transmitted via anetwork.
 20. The method of claim 19, wherein said network is theInternet.
 21. The method of claim 18, wherein said measurement istransmitted via a wireless protocol.
 22. The method of claim 21, whereinsaid wireless transmission is performed via coupling the input device toa cellular phone.
 23. The method of claim 21, wherein said wirelesstransmission is performed via coupling the input device to a pager. 24.The method of claim 21, wherein said input device contains a wirelesstransmission module.
 25. The method of claim 18, further comprising thestep of restricting user access by a pre-determined rule set.
 26. Themethod of claim 18, further comprising the step of processing theanalyte measurement to generate a profile.
 27. The method of claim 26,wherein the processing relates to correlating said analyte measurementwith behavioral attributes of the patient.
 28. The method of claim 18,wherein the analyte measurement is blood glucose level.